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General product and regulatory information only; this is not medical advice. Questions about contraception or infection prevention belong with a licensed clinician.
Short answer
A spermicidal condom is a condom whose lubricant contains the spermicide nonoxynol-9 (N-9). FDA regulates it as its own device type, Class II, under 21 CFR 884.5310. CDC does not recommend N-9 condoms for STI or HIV prevention, and a 2002 WHO expert meeting found no added protection over other lubricated condoms.
Definition and scope
Under 21 CFR 884.5310, a condom with spermicidal lubricant is a sheath that completely covers the penis with a closely fitting membrane, with a lubricant that contains the spermicidal agent nonoxynol-9. The regulation describes its use as contraceptive and prophylactic, meaning preventing transmission of venereal disease. The rule classifies the device as Class II (performance standards). In FDA’s classification database it appears as product code LTZ, “Condom With Nonoxynol-9,” in the Obstetrics/Gynecology specialty.
The defining feature is the lubricant, not the sheath. A condom sold without N-9 in the lubricant falls outside this regulation. For the wider route FDA uses to clear devices, see FDA 510(k) premarket notification.
How the spermicide fits into practice, according to named sources
WHO’s 2002 report notes N-9 is present in most spermicides, used over the past half-century in gels, creams, foams, suppositories, sponges and films. Laboratory tests in the 1970s and 1980s showed it could inactivate organisms that cause gonorrhoea and chlamydia and HIV, which raised hopes of infection protection; WHO states that clinical trials did not support those hopes.
CDC’s STI Treatment Guidelines (primary prevention methods) say spermicides containing N-9 might disrupt genital or rectal epithelium and have been associated with an increased risk for HIV infection, and that N-9 use has been associated with an increased risk of bacterial urinary tract infections among women.
Regulatory status compared with public-health guidance
| Source | What it says | Date and scope |
|---|---|---|
| FDA, 21 CFR 884.5310 | Defines the device by N-9 in the lubricant; Class II; used for contraceptive and prophylactic purposes | Current federal regulation text |
| CDC STI Treatment Guidelines | Condoms with N-9 are no more effective than condoms without N-9; N-9 alone or in a condom is not recommended for STI and HIV prevention | Current CDC treatment guidelines |
| WHO news release | No evidence that N-9 condoms gave more protection against pregnancy or STIs than silicone-lubricated condoms; such condoms should no longer be promoted | Published 28 June 2002; a dated expert-meeting statement |
The comparison shows that a device can remain defined in federal regulation while public-health bodies advise against relying on its spermicide. Regulation describes what the product is; guidance describes whether the spermicide adds benefit.
Related concepts
- Condom with spermicidal lubricant: the sheath plus N-9 lubricant, the subject of this page.
- Standalone spermicide: N-9 products such as gels, foams and films used without a condom. WHO describes N-9 used alone as only moderately effective for pregnancy prevention.
- Non-spermicidal lubricants: WHO notes silicone is the lubricant on most condoms in developing countries. For another lubricant category defined by FDA product code, see fertility-friendly lubricant and FDA product code PEB.
Do not confuse this product with a condom catheter, which is an external urinary collection device and unrelated to contraception.
Where it matters for labs, clinics and supply decisions
Staff reading a product label or catalogue entry can use the regulatory and guidance sources above to separate three questions. This is a reading checklist, not purchasing advice.
- Does the label name a spermicide? The 21 CFR 884.5310 definition turns on N-9 in the lubricant, so the product description should state it.
- Is the infection-prevention claim consistent with CDC? CDC states N-9 in a condom is not recommended for STI and HIV prevention, so an N-9 claim of added infection protection conflicts with that guidance.
- Is the pregnancy-prevention claim consistent with WHO? WHO’s 2002 meeting found no added pregnancy protection compared with silicone-lubricated condoms.
Product clearance records for devices can be searched in the openFDA classification and 510(k) data using the product code LTZ.
Common misunderstandings
“The spermicide protects against STIs.”
CDC states the opposite: N-9 alone or in a condom is not recommended for STI and HIV prevention, and N-9 has been associated with increased HIV risk. WHO also concluded that N-9 spermicides do not protect against cervical gonorrhoea and chlamydia.
“It is a different kind of condom.”
The sheath is the same type of device; the regulation distinguishes it by its lubricant.
“Guidance against the spermicide means the condom itself is the problem.”
WHO’s 2002 statement concerns the spermicide’s lack of added benefit and its possible adverse effects, not condoms as a device class.
FAQ
What is a spermicidal condom?
A condom lubricated with a spermicide, nonoxynol-9, as defined in 21 CFR 884.5310.
Is a spermicidal condom regulated differently from other condoms?
FDA lists it as a separate device type, Class II, with its own regulation number and product code (LTZ).
Does the spermicide add protection against pregnancy?
A 2002 WHO expert meeting found no evidence of more protection than silicone-lubricated condoms.
Does it protect against HIV or other STIs better?
No. CDC says condoms with N-9 are no more effective than those without it and does not recommend N-9 for STI and HIV prevention.
Sources
- U.S. FDA, 21 CFR 884.5310 Condom with spermicidal lubricant, checked 2026-10-30.
- openFDA, device classification database, product code LTZ, record last updated 2026-10-19, checked 2026-10-30.
- CDC, Sexually Transmitted Infections Treatment Guidelines: Primary Prevention Methods, checked 2026-10-30.
- WHO, Nonoxynol-9 ineffective in preventing HIV infection, 28 June 2002, checked 2026-10-30.
